Blood Thinner Heparin Was Intentionally Contaminated to Boost Company Profits, Lawsuit Claims

Makers of the blood-thinning drug heparin intentionally used a counterfeit active ingredient blamed for causing at least 100 deaths and hundreds of injuries to increase company profits, according to a lawsuit just filed by a California couple.

Brian and Tracy Underwood sued Baxter Healthcare Corp. this week in the Texarkana Division of the Eastern District of Texas, according to the Southeast Texas Record.

According to the suit, Tracy Underwood was administered multiple vials of heparin between October 2007 and March 2008 while she was hospitalized in Texas. Heparin is commonly used to prevent blood clots, particularly during heart surgeries. The liquid drug also is used in hospitals to clear intravenous lines of blockages.

Heparin Recall Launched

In January 2008, Baxter recalled heparin after it was discovered that patients administered the drug were dying and suffering severe adverse reactions. It was later determined that the Chinese manufacturer of the product, Scientific Protein Laboratories, had substituted a contaminated artificial active ingredient that was causing complications in patients.

In March 2009, dozens of people filed a class-action lawsuit against Baxter for injuries allegedly caused by the contaminated heparin. The patients’ lawsuit sought unspecified financial damages and other relief.

Intentional Contamination Alleged

According to the Underwoods’ lawsuit, the chemical posing as an active ingredient in the recalled heparin is not found in nature and is not approved by the Food and Drug Administration. The couple said Baxter used the counterfeit ingredient because it is cheaper than the bonafide ingredients but can mimic the drug’s actual active ingredient.

“Upon information and belief, the contaminant was intentionally introduced to dilute or to substitute the active pharmaceutical ingredient for heparin for the purpose of profit,” the lawsuit states.

As a result of being given heparin containing the counterfeit active ingredient, Tracey Underwood claims she developed superior vena cava syndrome, a condition caused when a large vein in the chest is compressed, resulting in restricted blood flow. The increased pressure in the veins causes fluid build-up in the face and arms.

Lawsuit Seeks Financial Damages

The Underwoods accuse Baxter of negligence for failing to disclose the results of tests on contaminated heparin, failing to act reasonably to recall the drugs, and failing to act as a reasonably prudent drug manufacturer. The lawsuit includes as causes of action negligence, manufacturing defect, and design defect, breach of implied and express warranties, according to the Record.

The plaintiffs are seeking damages for medical expenses, loss of consortium, physical pain and suffering, mental distress, lost income and loss of earning capacity, punitive damages, pre and post judgment interest, the Record reports.

The lawsuit will be transferred to the multidistrict litigation panel formed in the Northern District of Ohio to rule on pre-trial proceedings for all heparin lawsuits. About 50 lawsuits pending against Baxter for heparin injuries have been consolidated for pre-trial rulings and the first cases are now set to go to trial on November 2010, officials said.

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